Obtaining a Drug Manufacturing License in India involves a detailed process to ensure compliance with regulatory standards set forth by the Drugs and Cosmetics Act, 1940, and Rules thereunder. Here’s an overview of the process for obtaining a Drug Manufacturing License, considering both fresh applications and renewals (retention):

Types of Drug Manufacturing Licenses:

1. Manufacturing License for Allopathic Drugs:
   • Issued for the manufacture of allopathic medicines, including tablets, capsules, syrups, injections, etc.
2. Manufacturing License for Ayurvedic, Siddha, and Unani Drugs:
   • Issued for the manufacture of traditional medicines under the Ayurvedic, Siddha, and Unani systems.
3. Manufacturing License for Cosmetics:
   • Issued for the manufacture of cosmetics, including skin care products, hair care products, etc.

Adhere to GMP guidelines to ensure quality and safety of manufactured drugs or cosmetics. Maintain robust quality control measures and documentation as per regulatory requirements. Maintain detailed records of manufacturing processes, quality control tests, and batch-wise production.